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Project Manager

Reports To: Chief Operating Officer
Status: Exempt 

Position Summary
Reporting to the Chief Operating Officer and working closely with the R&D and Quality Assurance teams, the Project Manager is responsible to ensure the smooth, timely progression of the Company’s enzyme development projects from feasibility to design transfer, culminating in locked-down processes, revenue recognition, and customer satisfaction. Duties include, but are not limited to, preparation of customer RFP responses, shepherding projects through the Design Control process in coordination with R&D and QC/QA, and liaising with customers to provide regular status and progress sample evaluations. The Project Manager acts as the “glue” between the departments involved in product realization and is central to maintaining transparent communication and achieving customer satisfaction. Alphazyme maintains a commitment to Quality and a culture of continuous improvement, and the Project Manager is responsible to periodically propose opportunities to enhance the design process to improve customer satisfaction.

Key Features of the Role:

  • Lead project management activities for both internally- and externally sponsored custom enzyme projects, including planning activities
  • Steer enzyme products through the Development cycle, ensuring the timely completion of design reviews and critical path items, liaising between the R&D and QA teams to alleviate bottlenecks
  • Analyze ongoing data collection and communication of cross-functional key performance indicators (KPIs), dashboards and project plans

Job performance will involve a variety of activities including:

  • Manage projects in accordance with priorities set by the ELT, which may be adjusted from time to time
  • Co-develop proposals and budgets for externally sponsored projects with the COO
  • Serve as primary point-of-contact for communications regarding project status for both internally- and externally sponsored projects
  • Document new and/or shifting priorities by adjusting development plans and resource leveling; enable ongoing cross-functional tracking of status and visibility into upcoming project activities
  • Document product development project activities (i.e., Design History File/stage gate documentation) with input from extended team members
  • Serve as customer liaison on externally-sponsored projects and sampling initiatives
  • Ongoing Quality System management and updates of documentation to accurately reflect product development practices
  • Support periodic ISO 13485 internal audits in collaboration with VP Quality
  • Act as primary Product Development contact during external audit process
  • Lead Production Planning and associated Job Traveler system, including weekly planning meetings
  • Additional duties as assigned and as appropriate

Education / Experience / Skills

  • Minimum 5 years’ experience working in industrial biotechnology
  • Biotech Project Management experience is preferred
  • Bachelor’s degree from four-year college or university with life science concentration preferred
  • Experience in ISO/FDA Quality System Regulation environment, medical device preferred
  • Strong Protein Biochemistry, Microbiology, and/or Bioprocessing background
  • Excellent written and verbal communication skills
  • Initiative and organizational skills
  • Demonstrated scientific problem-solving skills, seeks “wins” for both the client and the company
  • Positive external and internal relationship management skills
  • Proficient with MS Office applications
  • Working knowledge of electronic documentation systems, data retrieval, and file formats
  • Ambitious, eager to learn and aptitude for technology
  • Proven ability to thrive in a dynamic, change oriented environment

About Alphazyme
Alphazyme was founded in 2018 by experts in the field of enzyme development and production with a track record of success and a passion for supporting innovators in molecular science. Our mission is to be the world’s premier partner for custom, industrial-scale molecular biology enzymes. We partner with the manufacturers of nucleic acid therapies and detection platforms to develop and produce affordable, reliable enzymes which meet the specifications of the rapidly expanding market for custom DNA and RNA molecules, genomic medicines and genetic tests. Consistent quality, scalable production, and compatibility with regulatory requirements are the hallmarks of our business.

Need a custom enzyme developed?
Need an enzyme manufactured to scale?
No problem!
Please contact us to discuss your custom project.